Reuse of hemodialyzers has been increasing steadily. Reuse is motivated by economies of reuse over disposal of hemodialyzers after each use. There has been a great demand for products which disinfect, sterilize or aid in the disinfection or sterilization of hemodialyzers for their reuse. In the context of this invention, "hemodialyzer" and "dialyzer" are used synonymously.
Manufacturers have introduced automated hardware for reprocessing dialyzers for reuse. For example, Renal Systems, Inc., has introduced a machine which disinfects dialyzers for reuse. Their RENATRON.TM. RS-8300 is a dialyzer reprocessing system for hollow fiber dialyzers. Seratronics, Inc., as well, has introduced a machine for disinfecting dialyzers. The Seratronics' DRS-4 is a microprocessor based system designed to reprocess hollow fiber hemodialyzers for multiple use. Disadvantages associated with automated machinery are rife. Capital outlays or leasing costs for these machines are high, maintenance must be performed routinely if breakdowns are to be avoided, and when breakdowns do occur, no alternatives are provided for reprocessing the dialyzers.
Manually disinfecting dialyzers for reuse presently is the most common practice followed by reusers in hospitals and hemodialysis clinics. Typically, dialyzers are rinsed and stored with a reuse, disinfectant solution. Current reuse techniques, however, vary from place to place. Moreover, present reuse techniques for disinfecting dialyzers require disconnection and disposal of blood lines and associated intravenous administration sets.
Reuse solutions for dialyzers are available, for example, The Sporicidin Co., manufactures a solution known as SPORICIDIN.RTM. Cold Sterilizing Solution which may be used for disinfecting and washing out dialyzers. Also, formaldehyde currently is being used for disinfecting and washing out dialyzers. U.S. Pat. No. 4,431,560, filed Dec. 27, 1982, Washing and Storage Solution for Separation Devices, to Lake, et al., [hereinafter cited as Lake] assigned to Baxter Travenol Laboratories, Inc., discloses an acidic solution for cleaning and storing blood dialyzers and other separation devices. A solution of about 1% monoperoxysuccinic acid and 8% acetic acid also may be used for cleaning and storing blood dialyzers and other separation devices, particularly intended for contact with blood after they have been used once.
It would be desirable to provide a procedure or method for disinfecting dialyzers, filters, membrane plasmapheresis devices and the like which may be quickly and uniformly performed in clinics and hospitals with minimal compromise to the sterility of the separation device. Such a method would avoid the disadvantages concomitant with specialized, automated machinery used for disinfecting dialyzers for reuse, namely, high cost, maintenance, and breakdown problems.
It would be expedient to provide a method and associated apparatus for disinfecting separation devices for blood, including dialyzers, filters, membrane plasmapheresis devices and the like, which would allow as many as possible associated blood lines and administration sets to be disinfected for reuse. The overall cost of the method and functionally related devices desirably would be less than the cost of providing a new separation device and new associated blood lines and administration sets.
It would be expedient if such a functionally related device organized the many administration set lines, blood lines and their peripheral lines. Moreover, such a device could be used with plugs for closing dialysate connectors on dialyzers to retain disinfecting reuse fluid in the dialysate compartment of the dialyzer.
It also would be desirable to neatly contain, for proper disposal, spent reuse solution not retained in the dialyzer and associated lines, by providing a receptacle for the solution.
Furthermore, it would be beneficial if connectors on the device had sealing caps to close any unused connectors thereby maintaining sterility and providing a closed system.